"Using Herbal Medicines: Advice to Consumers" is a new guidance document issued July 27 that informs consumers about how to avoid low-quality products on the market, the UK's Medicines & Healthcare products Regulatory Agency announces. The document warns that "any medicine - herbal or otherwise - has the potential to have adverse effects," and states that the safe use of herbals "has not been established" in pregnant women, breastfeeding mothers, children or the elderly. MHRA also explains that products bearing a PL (product license) or THR (Traditional Herbal Registration) symbol on their product labels are regulated by the government, while products with no symbols have not been assessed by the agency. The guidance is being issued in the wake of MHRA's efforts to remove a number of questionable products from the market, including Real Herbs' supplement that was advertised to "inhibit the growth of tumor" and Rena Chinese Medical Center's capsule that claimed to have "strong effects in controlling HIV"...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
